In Short
The Situation: The NMPA and CNIPA recently
jointly issued the Implementation Measures for the Early Resolution
Mechanism for Drug Patent Disputes. The CNIPA and China's
Supreme People's Court have each issued, separately, rules for
an Article 76 Proceeding that a patent holder could opt for against
a generic drug applicant.
The Result: The three recent legal rules have
unveiled detailed mechanisms of China's patent linkage system.
Unlike in the United States, patent holders may choose to commence
an Article 76 proceeding by means of a civil action before the
court and/or an administrative determination before the CNIPA. The
NMPA will grant a nine-month stay for marketing approval of the
generic drug application pending a judicial or administrative
decision. The first generic drug applicant that successfully
challenges the validity of listed patents and obtains marketing
approval will be granted a 12-month market exclusivity.
